More than a dozen health systems sued the federal government regarding its reinstituted registration policy for offsite clinics of 340B-eligible hospitals.
Last month, the Health Resources and Services Administration reversed a policy that streamlined 340B certification during the COVID-19 pandemic. Hospitals participating in the drug pricing program, which provides an estimated 25% to 50% discount on outpatient drugs for organizations that treat low-income and uninsured patients, must register offsite clinics with HRSA and list them on Medicare cost reports for those clinics to qualify for 340B.
The reinstated registration process will allegedly cause delays of 8 to 23 months, the health systems said in a complaint filed Oct. 31 in the U.S. District Court for the District of Columbia.
"HRSA’s new rule is costing covered entities hundreds of millions of dollars—and if left unchecked, the losses will quickly be measured by the billions," the complaint alleges.
The health systems, which include St. Louis-based Mercy Health; Chicago-based Northwestern Medicine; Philadelphia-based University of Pennsylvania Health System; Palo Alto, California-based Stanford Health Care; Yale New Haven (Connecticut) Health, are seeking to vacate the registration policy for offsite clinics of 340B hospitals.